User manual

2
User Manual
CHAPTER 2: WARNINGS AND CAUTIONS
WARNING: Indicates the possibility of injury to the user or operator.
CAUTION: Indicates the possibility of damage to the device.
NOTE: Places emphasis on an operating characteristic.
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
2.1 WARNINGS
•  is manual serves as a reference.  e instructions in this manual are not intended to supersede
the instructions of your health care professional. You should read and understand this entire
manual before using the device.
• Long term eff ects of the treatment of sleep disordered breathing and/or Cheyne Stokes
Respiration in patients with Congestive Heart Failure (CHF) or atrial fi brillation have not been
documented.  erefore, caution should be exercised when using this device on a patient with
CHF or atrial fi brillation.  e clinician should assess the relative risk and benefi ts of the therapy
on a case-by-case basis.
•  e prescription must be adjusted only by a trained health care professional.
•  e device provides positive pressure ventilation and is indicated for assisted ventilation.  is
system does not provide ventilation with guaranteed tidal volume delivery. Patients requiring
ventilation at predetermined tidal volumes are not candidates for pressure support ventilation.
•  is is not a life support ventilator.  e device is a non-continuous ventilator intended to augment
patient breathing. It is not intended to provide total ventilatory support. It may stop operating
with power failure or if a fault occurs in the product.
• You should report unusual chest pain, severe headache or increased breathlessness to your health
care professional.
• At low EPAP pressures, the fl ow through the exhalation port may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
• If the patient has a severe obstructive or restrictive spirometric defect, or severe daytime
hypercapnia or hypoxia, then the device may not be an appropriate treatment method.  is is due
to the level of ventilatory support that the device provides.
• Do not connect any equipment to the device unless recommended by Respironics or the health
care professional. Verify that an exhalation port is present to exhaust CO
2
from the circuit. If
circuit accessories other than those recommended by Respironics are connected to the device,
then pressure must be verifi ed. Use of these accessories may alter the pressure received, reducing
the eff ectiveness of treatment.
•  e device should be used only with masks and connectors recommended by Respironics or with
those recommended by the health care professional or respiratory therapist. A mask should not
be used unless the device is turned on and operating properly.  e exhalation port(s) associated
with the mask should never be blocked. In the event of a power failure or machine malfunction,
remove the mask.